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The U.S. Food and Drug Administration (FDA) funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. For consideration in the FY23 FDA Broad Agency Announcement (BAA), white papers are due by 5:00 p.m. EST on January 23, 2023.
The FDA BAA is open to all responsible sources, and small businesses are strongly encouraged to respond. Research areas of interest include:
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Methods to Assess Real-World Data (RWD) to serve as Real-World Evidence (RWE)
- Support the capture, harmonization, transmission, aggregation, analysis, and use of high-quality, interoperable diagnostic data from real-world settings to evaluate in vitro diagnostic devices and other medical product performance during clinical trial development and premarket review.
- Explore how real-world data obtained from in vitro diagnostic devices can be used to inform public health decision-making in the premarket setting.
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Methods to Assess Real-World Data (RWD) to Support Regulatory Decision-Making
- Support the capture, harmonization, transmission, aggregation, analysis, and use of high-quality, interoperable diagnostic data from real-world settings to aid in post-market review and/or surveillance of safety and performance of in vitro diagnostic devices and other medical products.
- Explore how real-world data obtained from in vitro diagnostic devices during post-market surveillance and data collection can be used to inform public health decision-making.
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Efforts to Harmonize Existing and Emerging Data Standards
- Improve existing or develop new approaches to enhance quality and consistency of regulatory submission data, and to harmonize standards for data synthesized across multiple sources, including data captured from in vitro diagnostic devices.
Questions?
If you have questions about the BAA program, contact FDABAA@fda.hhs.gov.
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